BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVIT AT-180

    MDR report key: 19861441 · Received July 30, 2024

    Report

    Report Number
    8030978-2024-65329
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    DPS
    PMA / PMN Number
    K183425
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT OCCASIONALLY HIGH-FREQUENCY SIGNAL ARTIFACTS ARE RECORDED DURING AN ECG ACQUISITION PERFORMED BY CARDIOVIT AT-180 ELECTROCARDIOGRAPHS. THESE ARTIFACTS WERE OCCASIONALLY MISCLASSIFIED BY THE ELECTROCARDIOGRAPH AS PACEMAKER IMPULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216234 CARDIOVIT AT-180 CARDIOVIT AT-180 DPS SCHILLER AG 0A.110000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown